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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA Warns of Medical Device Coating Separation Issues

The separation of coatings on certain intravascular medical devices has the potential to cause serious injuries to patients, the US Food and Drug Administration (FDA) warned on Monday.

FDA is trying to make health care providers aware that patients could be at risk if the hydrophilic and/or hydrophobic coatings separate (e.g., peel, flake, shed, delaminate, slough off) from devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems commonly used during minimally invasive procedures in the cerebrovascular, cardiovascular and peripheral vascular systems.

The lubricious coatings -- meant to decrease the friction between the device and blood vessels -- have been used for more than 20 years on millions of patients in minimally invasive procedures, FDA says.

But the agency has not concluded that any specific manufacturer or brand of devices is associated with higher risks than others.

FDA’s Center for Devices and Radiological Health said last month that in 2016 it would further investigate new methodologies and tools that more accurately predict the clinical impact of surface coatings, materials corrosion and additive manufacturing on device quality, performance and safety.

Reports

Since 1 January 2014, FDA has received about 500 medical device reports (MDRs) on the coating separations, including 11 that described patient deaths.

Of the 11 patient deaths from the MDRs, FDA notes that two of those weren’t attributed to the device coating, but the other nine described in the medical literature noted that “occlusion of blood vessels reportedly occurred due to embolization of coating particles from devices during heart and brain catheterization procedures contributing to clinical adverse events such as heart attack and bleeding inside the brain.”

FDA also warns: “It may be difficult for clinicians to associate these adverse events with malfunction of the coating; instead, they may mistakenly attribute the adverse events to other procedural complications or patient co-morbidities.”

Since 1 January 2010, FDA also says there have been 11 recalls linked to these device coatings peeling or flaking off.

“The majority of the recalls were associated with guidewires, but there have also been recalls for other types of devices including sheaths, retrieval devices and embolization device delivery wires used in the vasculature,” FDA says.

What Clinicians Can Do

Since the cause of the coating separation is multifactorial, and can be associated with factors including device design, device manufacturing, and use, current FDA analysis suggests that “use-related issues may be mitigated through proper device selection, preparation, and other considerations.”

Among those other considerations are:

Be aware that many devices are designed, labeled and indicated for specific uses. For example, the coating and performance of a device meant to be used in the peripheral vasculature may be different than a device meant to be used in the cerebral vasculature.

“When using two devices together (e.g., catheter and introducer sheath), ensure there is sufficient room for one to pass safely within the other, taking into consideration the features of the device (e.g., curved tip), and that some coatings may swell during use. For example, consider using a slightly larger French size for the introducer sheath than the catheter so there is sufficient room between the devices.”

Use caution when manipulating, advancing and/or withdrawing these devices through needles, metal cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels. Manipulation, advancement and/or withdrawal past sharp or beveled edges may result in destruction and/or separation of the outer coating which may lead to clinical adverse events.

Be aware that attempting to alter the shape of devices by bending, twisting, or similar methods may compromise the coating integrity and that damage to the coating may not always be noticeable to the naked eye.

Consider replacing a device if it does not move freely, is visibly kinked or otherwise damaged, or does not perform as expected.

During preconditioning of the coating, use only the recommended solution (e.g., normal saline, heparinized saline, sterile water, etc.). Solutions may not be interchangeable and may affect the hydrophilic and/or hydrophobic coatings differently.

Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.

Avoid pre-soaking devices for longer than instructed, as this may impact the coating performance.

Avoid wiping the device with dry gauze as this may damage the device coating.